R
redknight07
Fellow members of the cove, hope you can assist me in addressing this query regarding registration and listing:
Company ABC manufactures device X (class II). As part of device X, it uses two accessories which are classified as devices (one is class I and the other is class II) and are both manufactured by company LMN. Company ABC and LMN are both located within the US. The two accessories are used as per their intended use. If company ABC is just distributing these accessories, which happen to be devices, as part of the device X as well as separately and the label mentions specifically that company ABC is the distributor then does company ABC require to register and list these two devices with the FDA?
The devices are labeled at the facility of company LMN and state that company ABC are the distributors for those two devices. The label also includes part number assigned by ABC-the distributing company.
Does Company ABC then fall under the category of “Distributors that don’t import devices” and hence does not require registration and listing?
Or since the label includes the part number as assigned by the distributing company, they are hence considered as the relabeler?
http://www.fda.gov/MedicalDevices/D...istrationandListing/ucm053165.htm#definitions
Appreciate any feedback. Thanks.
Regards,
Aniket
Company ABC manufactures device X (class II). As part of device X, it uses two accessories which are classified as devices (one is class I and the other is class II) and are both manufactured by company LMN. Company ABC and LMN are both located within the US. The two accessories are used as per their intended use. If company ABC is just distributing these accessories, which happen to be devices, as part of the device X as well as separately and the label mentions specifically that company ABC is the distributor then does company ABC require to register and list these two devices with the FDA?
The devices are labeled at the facility of company LMN and state that company ABC are the distributors for those two devices. The label also includes part number assigned by ABC-the distributing company.
Does Company ABC then fall under the category of “Distributors that don’t import devices” and hence does not require registration and listing?
Or since the label includes the part number as assigned by the distributing company, they are hence considered as the relabeler?
http://www.fda.gov/MedicalDevices/D...istrationandListing/ucm053165.htm#definitions
Appreciate any feedback. Thanks.
Regards,
Aniket